HEALTH

Study: Parents confident in administering correct acetaminophen dose with AccuDial dosing label

BY Michael Johnsen

PALM BEACH GARDENS, Fla. — As many as 97% of parents are confident they administered the correct dose of acetaminophen when using AccuDial Pharmaceutical’s weight-based dosing label, according to research published earlier this year.

In 2011 Concentric Research conducted a two-phase label comprehension and dosing study on behalf of AccuDial Pharmaceutical. In phase one, 61 adult parents/caregivers with children below 18 years old participated. In phase two 565 adult parents/caregivers with children below 18 years old participated. Of those, 10% of the parents were in the lower literacy category based on the REALM literacy test that all participants were required to take prior to participating in the study.

The primary objective of the study was to evaluate the ability of parents with children below age 18 to understand the dosing instructions of AccuDial’s Children’s Acetaminophen product with a new rotating weight-based dosing label (dosing comprehension) and to demonstrate their understanding by measuring a dose (dosing behavior) when given various scenarios.

As part of the phase one study, 30 participants evaluated the AccuDial acetaminophen dosing chart, and 31 participants evaluated the five Age/Weight Range Dosing chart — the dosing chart that national brand and store brand manufacturers display on their product labels.

Parents that evaluated AccuDial scored significantly higher — between 84% and 93% — in their comprehension of the correct amount of medication to give a child. There was less comprehension associated with using the Age/Weight Ranging Dosing chart.

In situations where a child’s age and weight match the dosing directions on the Age/Weight Ranging Dosing chart, the comprehension was 80.6%. However, when the child’s age and weight did not match the age/weight range on the chart, dosing comprehensions was between 58% and 67%. Parents were less sure of how to dose when their children were heavier than indicated on the chart against the corresponding age range.

The phase two study was conducted in 10 cities across the United States. Comprehension results for AccuDial ranged between 84% and 97%, and were statistically comparable to the comprehension results in phase one. The dosing section in phase two produced slightly better results, as 97% of parents were confident they administered the correct amount of medication.

In phase one AccuDial included a calibrated dosing spoon, and the Age/Weight Comparator product used a calibrated dosing cup. Between phase one and phase two, AccuDial replaced the calibrated dosing spoon with an oral syringe (and a Push-In Bottle Adapter). The syringe proved easier to measure the correct amount of medication, was easier to administer the medication directly from the syringe and parents were concerned that the thick viscosity of acetaminophen caused between .5 mL and 1.5 mL to remain in a dosing cup or spoon.

Subsequently, AccuDial includes a Push-in Bottle Adapter and oral syringe with all acetaminophen products.

Click here for the complete study results.

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HEALTH

FDA cracks down on violators of dietary supplement regulations

BY Michael Johnsen

 SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations. 

A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

Berst marketed the products on his website as alternative herbal medicine for such serious disease conditions as cataracts, viral and bacterial infections, and cancer. Under the Federal Food, Drug and Cosmetic Act, a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. Berst’s products are drugs that have not been approved by FDA for their claimed uses, the FDA noted.

“This company has ignored previous FDA warnings, and has continued to produce and distribute products in violation of federal law,” stated Melinda Plaisier, FDA’s acting associate commissioner for regulatory affairs. “The FDA continues to protect public health by seeking enforcement action against companies that are identified as violating our manufacturing and drug approval requirements.”

The FDA sought the injunction after Berst failed to comply with previous warnings, continuing to market products in violation of federal law. Berst is appealing the injunction with the 9th Circuit Court of Appeals, the FDA reported. 

And FDA secured a cease-and-desist agreement from Venus Pharmaceuticals International of Hauppauge, N.Y. Venus CEO Bharat Kakumanu has agreed to stop production and distribution of dietary supplements into U.S. commerce, and to recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice regulations. In addition, the firm is prohibited from exporting products unless such activity is in compliance with FDA laws and regulations.

“When a company violates public health protections, they put consumers at risk,” Plaisier said. “Our goal at the FDA is to ensure that consumers have access to dietary supplements that meet good manufacturing practices, so that the products do not harm consumers.”

As part of the consent decree, the company must implement a series of corrective actions before it can resume production of dietary supplements. The actions include changing procedures for manufacturing, packaging and labeling dietary supplements so that they meet FDA requirements. In addition, the company must hire an outside auditor to oversee and review progress in implementing the needed changes.

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B.RYDER says:
Jan-25-2013 05:09 am

Nothing good can happen if a company ignores the warnings from FDA and continue to produce and distribute medicines that are a violation of federal law. My aunt found The proper diet after a friend suggested to try some herbs produced by an American Company, she lost 5 pounds and wants to lose more, her courage is immense.

blackhippy says:
Oct-26-2012 07:11 pm

The FDA doesn't mess around. However are the people buying the product really doing the research for the herbal dietary supplements or just blindly trying anything to slim their waste? For example, I have high cholesterol and before I just swallow anything that says that it will lower my cholesterol I do a little research about it such as go to www.herbalent.com/?p=114 and see that Guggul and fiber are the best methods if I want to go the natural route. Pretty simple people.

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Novartis outsources production to bring back top-selling OTC brands to market

BY Michael Johnsen

 BASEL, Switzerland — Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic. First shipments to retailers were made in October. 

The products will be available to consumers over the course of the fourth quarter, Novartis announced. And it is unlikely that any shipments will come out of the Lincoln plant anytime this year, as the restart of commercial production is taking longer than the company originally anticipated.

"We’ve announced the launch of Excedrin Migraine, Triaminic, Lamisil and Excedrin Extra Strength," Brian McNamara, division head Novartis OTC, told analysts Thursday. "We’re continuing to focus on bringing up our biggest brands at third parties, as we speak, to relaunch for next year. The margin impact is short-term."

"I’m still not happy with the progress that we’re making in Lincoln," Joseph Jimenez, Novartis CEO, told analysts. "So we are ensuring our return to market through third-party manufacturers, which will reduce our dependence on the remediation efforts at Lincoln. … We’re making progress, but it’s just not fast enough, and we’re returning to market with co-packers," he said. "We have very strong relaunch plans in place, and we’re executing now to regain our market share."

And Novartis won’t be getting out of the consumer health business anytime soon, Jimenez added, responding to an analyst question on what parameters would have to be met before Novartis considered exiting a particular division. "Consumer health plays a very important role. While it’s not a huge division, it’s still a division that pre-Lincoln generated over $3 billion in sales and will be a good grower," he said. "Strong brands, so strong consumer loyalty as evidenced by all of those consumers in the U.S. who are writing us and asking us to bring back Excedrin because nothing else works, in their mind. So these are very, very strong brands, and Consumer Health plays a very important role."

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